Efficacy of Buffered Hypertonic Saline(BHS)Nasal Irrigation in Allergic Rhinitis (AR) Children

Allergic Rhinitis Clinical Trial

Official title:

Efficacy of Buffered Hypertonic Saline Nasal Irrigation in Children With Symptomatic Allergic Rhinitis : A Randomized Double-blind Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441778
• Other study ID #: MTU-PE-2-CR038-038/53
• Secondary ID: 14/2553
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2011
• Last updated: September 27, 2011
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: September 2011
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether buffered hypertonic saline (BHS) is superior to normal saline (NSS) for improving mucociliary function and relief nasal symptoms in children with allergic rhinitis.

Description:

1. BHS is superior to NSS for improving mucociliary function that by measure saccharine clearance time(SCT)at 10 minute after nasal irrigation compare to baseline.

2. BHS is superior to NSS for clinical effectiveness at short period and 1 month follow up

• at short period: compare the following results at baseline and 10 minute after nasal irrigation

1. total nasal symptom score(TNSS)

2. satisfaction to nasal irrigation

3. side effect

• at 2 and 4 weeks follow up : compare the following results at baseline and 10 minute after nasal irrigation

1. quality of life(by specific questionnaire for Thai allergic rhinoconjunctivitis patient)

2. medication use to relieve AR symptom(from diary record)

3. compliance for nasal irrigation (from diary record)

4. side effect (from diary record)

5. overall satisfaction to nasal irrigation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

1. age 6-15 years

2. diagnosed AR obtained by history, physical examination and positive skin prick test or nasal cytology

3. TNSS = 4 at the first visit of this study

Exclusion Criteria:

1. Patients with a history of nasal anatomical defects

2. Abnormal nasal ciliary function or an upper respiratory tract infection in the preceding 2 weeks

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• NSS nasal irrigation salt
nasal irrigation twice daily for 4 weeks period
• BHS nasal irrigation salt
nasal irrigation twice daily for 4 weeks period

Locations

Country	Name	City	State
Thailand	Araya Satdabudha	Klong luang	Pratumthanee

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in SCT at 10 minute after nasal irrigation of BHS and NSS	SCT method : subjects seated with their head upright. A rhinoprobe was used to place a small piece of saccharine on the medial aspect of the inferior turbinate approximately 1 cm, posterior to the nasal vestibule. The SCT was recorded as the subject's first perception of a sweet taste.	baseline, 10 minute after nasal irrigaiton	Yes
Secondary	The effect of BHS and NSS on clinical effectiveness	evaluate total nasal symptom score, side effect, satisfaction for nasal irrigation, quality of life at 1st visit, 2nd week and 4 week follow up	1st visit, 2nd week and 4 week follow up	Yes